PROCESS DEVELOPMENTAt AGC Biologics, we have developed more than 200 mammalian, bacteria and yeast-based processes, giving us the insight necessary to identify and optimize development parameters that are critical for achieving a high-quality, cost-effective manufacturing process for your product.
Developing an efficient, scalable, validated, and cost-effective manufacturing process is essential for success in today’s competitive biologics markets. Whether you need assistance developing a new process, are improving existing processes, or are preparing to manufacture your product, you will benefit from our in-depth expertise.
CGMP MANUFACTURINGAGC Biologics has successfully manufactured more than 200 biological products for pre-clinical studies through commercial approvals. Our global facilities across the United States, Europe, and Asia offer multiple cGMP manufacturing lines and a variety of scales for mammalian cell culture and microbial fermentation.
The innovative design of our state-of-the art facilities allows for capacity and technological flexibility, while ensuring compliance with the strict biopharmaceutical regulations required for cGMP operations. Our dedicated and experienced technical teams are committed to helping each client meet its clinical and commercial goals.
QUALITY and REGULATORYQuality matters — to patients, regulatory authorities and our clients. AGC Biologics’ quality organization provides a comprehensive suite of Quality Assurance (QA) and Quality Control (QC) services. Highly trained Quality Units maintain strict quality systems at each of our manufacturing facilities to support our cGMP manufacturing efforts and to ensure compliance with all regulatory requirements.
Our US site is commercially approved by the U.S. Food and Drug Administration (FDA) for commercial cGMP production of a protein therapeutic product. The site also recently completed a successful pre-approval inspection (PAI) for a second product. In addition, our Copenhagen facility completed successful pre-approval inspections by FDA and the European Medical Authorities in 2015 and is awaiting approval of this product.
Process validation is a critical and significant activity for customers preparing for commercial approval. AGC Biologics’ well-defined approach and supporting Quality Systems provide a straightforward path through process validation.
